In a lawsuit filed in Marshall, Texas, a man alleges the anxiety he experienced after the recall of Sprint Fidelis leads by Medtronic lead him to have Post Traumatic Stress Disorder (PTSD) and to seek a psychiatrist. He also claims that he has experienced multiple unnecessary shocks from his defibrillator that can only be attributable […]
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Lawsuit Alleges PTSD Due to Recall
February 20th, 2008 · No Comments
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Medtronic Sparks Congressional Inquiry
November 7th, 2007 · No Comments
The Medtronic recall of their Sprint Fidelis leads has sparked an investigation by Congress into the processes the FDA uses to approve implantable medical devices. It is being undertaken by the House of Representatives Oversight and Government Reform Committee.
Last month, Medtronic recalled their defibrillators feature Sprint Fidelis leads after they determined the leads had broken […]
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Medtronic Shown to Drag Feet on Removing Product from Market
October 30th, 2007 · No Comments
Medtronic was shown to have known for months that its Spirit Fidelis Defibrillator Leads were fracturing at higher-than-normal rates for months and yet took their own sweet time pulling the product from the market. They even went so far as to blame physicians for the defects rather than accept responsibility. The FDA, which did not […]
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